Prevail Global Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Prevail DCB: The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
Agent DCB: The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).
Study summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Eligibility
Primary outcome measure(s)
- ISR Cohort Primary Analysis — 1 year post-procedure
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority - DNSV Cohort Primary Analysis — 1 year post-procedure
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
Trial sites (79)
| Facility | City | Region | Status |
|---|---|---|---|
| Cardiology P.C. | Birmingham | Alabama | Recruiting |
| The University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Huntsville Hospital | Huntsville | Alabama | Recruiting |
| Carondelet Saint Marys | Tucson | Arizona | Recruiting |
| John L McClellan Memorial Veterans Hospital | Little Rock | Arkansas | Recruiting |
| Stanford Hospital & Clinics | Stanford | California | Recruiting |
| Medical Center of the Rockies | Loveland | Colorado | Recruiting |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | Recruiting |
| BayCare Health System | Clearwater | Florida | Recruiting |
| North Florida Regional Medical Center | Gainesville | Florida | Recruiting |
| University of Miami Hospital | Miami | Florida | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | Recruiting |
| Piedmont Atlanta Hospital | Atlanta | Georgia | Recruiting |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | Recruiting |
| Midwest Cardiovascular Institute | Naperville | Illinois | Recruiting |
| Parkview Health | Fort Wayne | Indiana | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) | Overland Park | Kansas | Recruiting |
| Ascension Via Christi Saint Francis | Wichita | Kansas | Recruiting |
| Saint Elizabeth Healthcare | Edgewood | Kentucky | Recruiting |
| Norton Heart and Vascular Institute | Louisville | Kentucky | Recruiting |
| University of Michigan Health System - University Hospital | Ann Arbor | Michigan | Recruiting |
| Corewell Health | Grand Rapids | Michigan | Recruiting |
| Saint Joseph Mercy Ann Arbor | Ypsilanti | Michigan | Recruiting |
| M Health Fairview Clinic | Edina | Minnesota | Withdrawn |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | Recruiting |
| CentraCare Heart & Vascular Center MN - Saint Cloud Hospital | Saint Cloud | Minnesota | Recruiting |
| Saint Lukes Mid America Heart Institute | Kansas City | Missouri | Recruiting |
| Providence Saint Patrick Hospital | Missoula | Montana | Recruiting |
| Virtua Our Lady of Lourdes Hospital | Camden | New Jersey | Recruiting |
| The Valley Hospital | Paramus | New Jersey | Recruiting |
| Kaleida Health | Buffalo | New York | Recruiting |
| Northwell Health North Shore University Hospital | Manhasset | New York | Recruiting |
| Cumc/Nyph | New York | New York | Recruiting |
| Montefiore Medical Center | New York | New York | Recruiting |
| Saint Francis Hospital (Roslyn NY) | Roslyn | New York | Recruiting |
| The Moses H Cone Memorial Hospital | Greensboro | North Carolina | Recruiting |
| Novant Health New Hanover Regional Medical Center | Wilmington | North Carolina | Recruiting |
| The Lindner Research Center | Cincinnati | Ohio | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
+ 39 more sites — see the full list on the official registry below.
More Medtronic Vascular trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06535854 on ClinicalTrials.gov ↗ ← All trials in the UK